Abstract
The safety and efficacy of S-1 plus cisplatin in Chinese advanced gastric cancer patients in first line setting is unknown. In this pilot study, patients with advanced gastric or gastro-esophageal junction adenocarcinoma were enrolled and randomly assigned in a 1:1 ratio to receive S-1 plus cisplatin (CS group) or 5-FU plus cisplatin (CF group). The primary endpoint was time to progression (TTP). Secondary end points included overall survival (OS) and safety. This study was registered on ClinicalTrials. Gov, number NCT01198392. A total of 236 patients were enrolled. Median TTP was 5.51 months in CS group compared with 4.62 months in CF group [hazard ratio (HR) 1.028, 95% confidential interval (CI) 0.758-1.394, p = 0.859]. Median OS was 10.00 months and 10.46 months in CS and CF groups (HR 1.046, 95%CI 0.709-1.543, p = 0.820), respectively. The most common adverse events in both groups were anemia, leukopenia, neutropenia, nausea, thrombocytopenia, vomiting, anorexia and diarrhea. We find that S-1 plus cisplatin is an effective and tolerable option for advanced gastric or gastro-esophageal junction adenocarcinoma patients in China.
Highlights
The incidence rate of gastric carcinoma varies dramatically worldwide and it is high in Eastern Asia, especially in China [1]
Patients assigned to S-1 had a 0.9 month longer time to progression (TTP) than those allocated to a continuous infusion of fluorouracil
Taken together with our findings, S-1 can be an alternative option for continuous infusion of fluorouracil in China
Summary
The incidence rate of gastric carcinoma varies dramatically worldwide and it is high in Eastern Asia, especially in China [1]. Ajani JA et al compared cisplatin/S-1 (CS) and cisplatin/5-fluorouracil (CF) in the first-line chemotherapy of AGC in a non-inferiority setting (FLAGS) and they found that CS was non-inferior to CF with a lesser toxicity profile [17]. Jin M et al used S-1 monotherapy as second-line chemotherapy in AGC patients who had previously treated with cisplatin/ infusional fluorouracil and they found that S-1 monotherapy provided mild response rate and overall survival (OS) as well as favorable toxicity profile in the second-line setting for AGC patients [19]. We compared the effect of CS and CF in the first-line treatment for Chinese AGC patients, using the domestic agent of S-1 (produced by Shenzhen Wanle Pharmacy Company). This study was designed in 2008, before the publication of FLAGS study
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